Myct-allergen from the pollen of trees for diagnosis and treatment (Mixt-allergenum e pollen arbor)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for cutaneous scarification, intradermal and subcutaneous administration
Composition:

Mikst allergens from pollen:

- trees for diagnosis and treatment (oak tree, alder sticky, birch hanging, maple ash, hazel (common hazel), common ash);

- meadow grasses for diagnostics and treatment (timothy grass, hedgehogs, ryegrass pasture, bonfire, fescue meadow grass, cedar grass, meadow foxgrass, meadow grasshopper);

- weeds and sunflower for diagnosis and treatment (wormwood wormwood, bitter wormwood, Tatar swan, annual sunflower).

Pollen mixed-allergens, solutions for cutaneous scarification, intradermal and subcutaneous administration is a water-salt extract of protein-polysaccharide complexes isolated from the pollen of the corresponding plant species by extraction with a neutral phosphate buffer solution.

The content of protein nitrogen is 10000 ± 2500 PNU/ ml.

Excipients: sodium chloride - 5 mg; sodium dihydrogen phosphate, 12-water-0.56 mg; Potassium phosphate monosubstituted - 0.36 mg; preservative - phenol from 0,2 to 0,4%; water for injections.

Description:

Mikst-allergen from pollen of weeds and sunflower - transparent liquid from yellow to brown color; mix-allergen from the pollen of trees - a transparent liquid of brown color; mixed-allergen from pollen of meadow grasses - a transparent liquid of yellow color.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Pollen allergens
    • Pharmacodynamics:Immunological properties
    The main active principle of pollen mix-allergens is the protein-polysaccharide complex, which makes it possible to diagnose a hypersensitivity to the entire complex, or a particular kind of pollen, which is part of the mixt-allergen, and apply it to immunotherapy for pollinosis and atopic bronchial asthma.
    Indications:

    Specific diagnostics and specific immunotherapy of pollenosis and atopic bronchial asthma caused by pollen of trees (oak, alder, sticky, birch, maple, ashwood (common hazel), common ash), pollen of weeds and sunflower of the annual (ragwort, wormwood, the Tatar swan), pollen of meadow grasses (timothy grass, hedgehog,ryegrass pasture, bonfire straight, fescue fescue, wild grass creeping, foxtail meadow, bluegrass meadow).

    Indications for diagnosis are clinical manifestations of the disease and history data, and for immunotherapy, skin test data with a specific mixt-allergen.

    When carrying out specific diagnostics and immunotherapy, children should be guided by the order of the Ministry of Health of the Russian Federation of 04.11.2002 "On improving allergic care for children in the Russian Federation."

    Contraindications:

    Contraindications for specific immunotherapy:

    1. An aggravation of an allergic disease.

    2. Severe form of atopic eczema.

    3. Autoimmune diseases.

    4. Immunodeficiency conditions.

    5. Acute infection.

    6. Tuberculosis of any localization in the period of exacerbation.

    7. Malignant neoplasms and blood diseases.

    8. Chronic diseases in the stage of decompensation.

    9. Cardiovascular diseases.

    10. Pregnancy and lactation.

    11. Mental illness in the period of exacerbation.

    12. Any form of hormonal therapy, therapy with antihistamines and bronchospasmolytic drugs.

    Contraindications for specific diagnostics:

    1. Exacerbation of an allergic disease.

    2. Acute infection.

    3.Chronic diseases in the stage of decompensation.

    4. Tuberculosis of any localization in the period of exacerbation.

    5. Systemic diseases of connective tissue.

    6. Any form of hormonal therapy, therapy with antihistamines and bronchospasmolytic drugs.

    Dosing and Administration:

    Skin tests and treatment with mixt-allergens should be carried out through:

    - 1 week after tuberculin test;

    - 2 weeks after the use of inactivated vaccines and antihistamine therapy;

    - 4 weeks after the use of live vaccines;

    - 8-12 weeks after the application of the BCG vaccine.

    In order to identify contraindications, the doctor on the day of setting allergic tests and on the day of specific immunotherapy conducts an examination of the patient.

    I. Specific diagnostics.

    The preparation is used for setting up skin tests (scarification, intradermal and prik test).

    In a patient who has an increased sensitivity to this mixst-allergen complex, an immediate blistering reaction (positive result) arises. The question of the necessity of setting skin tests with individual monoallergens, which are part of the mixt-allergen, is decided by the allergist doctor.

    The setting of skin tests is carried out with a mixt-allergen containing 10000 ± 2500 PNU/ ml. In patients with a high degree of sensitization, it is possible to apply the drug at a concentration of 5000 ± 1500 PNU/ ml. If there is no reaction to the skin test at a concentration of 10,000 ± 2,500 PNU/ ml, go to its intradermal administration at a dose of 0.02 ml at a concentration of 1000 ± 250 PNU/ ml. The preparation is diluted with a diluting liquid. The diluted drug is not stored.

    Scarification of allergic skin tests

    Scarification allergic tests are placed on the inner surface of the forearm or on the skin of the back. At the same time with the mixt-allergen it is allowed to conduct up to 15 samples with different pollen allergens, in addition to the plant species that make up the mixed-allergen. For 2-3 days before the setting of skin tests, antihistamines should be canceled. In case of doubtful results, skin tests can be repeated two days after the local reaction to the previous samples subsided. In case of a positive result, skin tests with pollen allergens can be repeated no more than once a month.

    A metal cap of vials (with mixed-allergen or test-control liquid) is rubbed with alcohol.

    Remove the central cap of the cap using a sterile forceps, and pierce the rubber plug, pretreated with alcohol, with a sterile needle.

    The skin of the inner surface of the forearm is wiped with 70 ° alcohol and allowed to dry.

    On the disinfected skin with a syringe, drop a test mixst-allergen and a drop of test-control fluid, at a distance (30 ± 10) mm from each other. Simultaneously, put a scarification sample with a drop of 0.01% histamine solution, a positive reaction to which no less than "+" indicates the presence of sufficient skin reactivity.

    Sterile scarifiers or sterile disposable injection needles separate for the mixt-allergen and for each patient, through drops of mixed-allergen, test-control fluid and histamine solution, two parallel scratches with a length of 5 mm are applied so as not to damage the blood vessels of the skin.

    After 5-10 minutes, sterile cotton buds "drip" drops of test-control fluid and mixed-allergen at the scratch site (a cotton swab should be separate for each drop of allergens, histamine and test-control liquid).

    If the scarification sample gives a negative reaction, and the anamnesis is suspected of increased sensitivity to plant pollen, which is part of the mixt-allergen, or if it is necessary to perform allergometric titration before the start of specific immunotherapy, put intradermal tests.

    Injection of intradermal samples

    Intradermal tests are performed on the inner surface of the forearm. The skin is pulled downward by moving the finger downwards, the needle is inserted at an angle of 15 ° to the surface of the skin, and it must be ensured that the needle hole is completely hidden in the epidermis, the needle must be thin with a short point.

    Sterile single-use, separate for the mixed-allergen and for each patient with tuberculin-type syringes with a 0.02 ml scale scale, 0.02 ml of mixed-allergen and test-control liquid, strictly 0.012 ml,% Histamine is determined by the method of scarification. Mixt-allergen, typed in a syringe, can not be poured back into the vial.

    Diagnosis with the test prick (prik-test) is carried out in accordance with the methodical recommendations M3 USSR 10-11 / 20 of March 10, 1985.

    Evaluation of diagnostic skin tests

    The result of the diagnostic tests is taken into account after 15-20 minutes (immediate reaction). A specific reaction to a mixt-allergen is judged only if there is no response to the test control fluid and if there is a positive sample for histamine (not less than "+").

    Scheme of accounting for skin reactions (scarification, prik-test)

    Evaluation of reaction

    Conditional designations

    The size and nature of the reaction

    Negative

    -

    Absence of blistering and hyperemia;

    Positive

    +

    Blister 2-3 mm, hyperemia;

    Positive

    ++

    Blister 4-5 mm, hyperemia;

    Positive

    +++

    Blister 6-10 ml, hyperemia;

    Blister 6-10 mm with pseudopodia, hyperemia;

    Positive

    ++++

    Blister more than 10 mm, hyperemia;

    Blister more than 10 mm with pseudopodia, hyperemia.

    The scheme of accounting for skin reactions (intradermal)

    Evaluation of reaction

    Conditional designations

    The size and nature of the reaction

    Negative

    -

    Dimensions are the same as in the control.

    Positive

    +

    A papule with a diameter of 4-7 mm, hyperemia.

    Positive

    ++

    Papula 8-14 mm in diameter, hyperemia.

    Positive

    +++

    Papula 15-20 mm in diameter with pseudopodia, hyperemia. The papule is more than 20 mm in diameter with pseudopodia and (or)

    Positive

    ++++

    lymphangitis, hyperemia.

    II. Specific immunotherapy.

    Specific immunotherapy is indicated in cases where it is impossible to exclude the contact of a sensitized patient with an allergen. Indications for specific immunotherapy are determined by the allergist doctor on the basis of the history, clinical manifestations of the disease, the results of skin testing, taking into account contraindications.

    Immunotherapy with mixt-allergen is carried out by patients who have been sensitized to all types of pollen included in the complex preparation.

    Immunotherapy starts with a dose 10 times lower than the one that caused a minimal positive reaction, with intradermal injection.

    Mixt-allergen with specific immunotherapy is administered subcutaneously.

    For the preparation and use of dilutions of mixed-allergen in aseptic conditions, the responsibility is borne by the allergist doctor.

    An approximate scheme of specific immunotherapy for pollinosis

    Breeding mixed allergen

    PNU/ ml

    Dose (ml)

    Notes

    1

    2

    3

    4

    1:100 000

    0,1

    0,1

    0,2

    0,4

    0,8

    Specific immunotherapy begins no later than 1.5 months before the beginning of flowering.

    Injections are made subcutaneously in the region of the lower third of the shoulder.The first injection (when diluting the allergen 10-5,10-4, 10-3) are done daily or every other day, subsequent injections (dilutions of 10-2, 10-1) - with an interval of 7-10 days. The dose of the allergen is 0.9-1.0 ml in dilution 10-1 repeat with an interval of 5-7 days before the flowering of trees and grasses. The period of use of the allergen after its dilution is 1 month. After each injection of the allergen, the patient is observed in the office for 40-60 minutes. The doctor notes the skin reaction at the site of the allergen injection and the general condition of the patient.

    Contraindication to increase the dose is a local reaction in the form of an infiltrate larger than 25 mm, arising during the day at the injection site, the general reaction of the body, the aggravation of the underlying disease. In these cases, the dose is reduced, the intervals between injections are extended until good tolerability is established. A detailed description of the method of specific immunotherapy is presented in the methodical letter of the Ministry of Health of the USSR "Application of allergens of non-infectious origin ..." A.D. Ado, S.M. Titova, Yu.A. Poroshin. Moscow. 1969

    1:10 000

    1,0

    0,1

    0,2

    0,4

    0,8

    1:1000

    10,0

    0,1

    0,2

    0,4

    0,8

    1:100

    100,0

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    1,0

    1:10

    1000,0

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    1,0

    Side effects:

    Local reaction to mixed-allergen occurs after 15-20 minutes (immediate reaction). In particularly sensitive patients, a systemic allergic reaction and anaphylactic shock may occur.In this regard, in the office, where specific diagnostics and specific immunotherapy of patients are carried out, there should be pharmacological preparations, antishock therapy products and tools for emergency treatment.

    Assisting with general reactions and anaphylactic shock

    In cases where during the introduction of a mixed-allergen for diagnostic or therapeutic purposes, the patient develops general weakness or agitation, anxiety, a feeling of heat throughout the body, redness of the face, rash, cough, shortness of breath, abdominal pain, the following measures should be taken.

    First aid first aid

    Immediately stop the injection of mixed-allergen; lay the patient (head below the legs) to turn his head to the side, push the lower jaw, remove the removable dentures.

    1. If the drug was injected into the limb, apply a tourniquet above the insertion site to 25 min.

    2. Finish the injection site with 0.3-0.5 ml 0.1% solution of adrenaline with 4.5 ml of a 0.9% solution of sodium chloride.

    3. In the limb, free from the tourniquet, subcutaneously or intramuscularly 0.3-0.5 ml of a 0.1% solution of epinephrine (children 0.05-0.3 ml).

    4. Place an ice or a heating pad with cold water at the injection site for 10-15 minutes.

    5. Urgently call a doctor.

    First medical aid

    If steps 1-5 are fulfilled and there is no effect, you should:

    1. Enter 0.3-0.5 ml (children 0.05-0.3 ml) 0.1% solution of epinephrine subcutaneously at intervals of 5-10 minutes. The multiplicity and dose of adrenaline administered depends on the severity of the reaction and blood pressure. In severe anaphylactic shock, the adrenaline solution must be administered intravenously in 20 ml of a 0.9% solution of sodium chloride. The total dose of epinephrine should not exceed 2 ml (children 1 ml) 0.1% solution. It should be remembered that the repeated administration of small doses of epinephrine is more effective than single doses of a large dose.

    2. If the arterial pressure does not stabilize, it is necessary to urgently begin intravenous drip norepinephrine (or mezatonum) injection 0.2-1.0-2.0 ml per 500.0 ml 0.9% solution of sodium chloride.

    3. Intramuscularly or intravenously, inject glucocorticosteroid drugs: prednisolone 60-120 mg (children 40-100 mg), dexamethasone 8-16 mg (children 4-8 mg) or hydrocortisone succinate or hemisuccinate 125-250 mg (children 25-125 mg).

    4. Intramuscularly inject 2.0 ml (children 0.5-1.5 ml) solution of 0.1% Tavegil solution or 2.5% suprastin solution.

    5. When bronhospazme intravenously 10.0 ml (2-3 ml) for children, 2.4% solution of euphyllinum on a 0.9% solution of sodium chloride.

    6. Cardiac glycosides, respiratory analeptics (strophanthine, korglikon, kordiamin) are introduced according to the indications.

    7. If necessary, suck off mucus from the respiratory tract, vomit and carry out oxygen therapy.

    All patients with anaphylactic shock are hospitalized. Transportation of patients is made after removal from the threatening state by the resuscitation team, because during the evacuation, a repeated drop in blood pressure and the development of collapse are possible.

    Doses of drugs administered and the tactics of the doctor are determined by the clinical picture, but in all cases it is necessary, first of all, the administration of epinephrine, glucocorticoids, antihistamines.

    The introduction of antihistamine preparations phenothiazine series (pifolen, diprazine, etc.) and calcium preparations is not recommended.

    Interaction:

    Interaction with other drugs has not been established.

    Form release / dosage:A solution for cutaneous scarification, intradermal and subcutaneous administration, 10000 PNU / ml.
    Packaging:

    Mixt-allergen is released as a kit:

    -2 bottles of mixed allergen from pollen of trees for diagnosis and treatment (oak, oak, sticky, birch, maple, ashwood (common hazel), ash), or

    - 2 bottles of mixed-allergen from pollen of meadow grasses for diagnosis and treatment (timothy grass, hedgehog, ragrace pasture, campfire, meadow fescue, grassy creeper, meadow foxgrass, meadow grassland) or

    - 2 flavors of mixed allergen from weed grass and sunflower pollen for diagnosis and treatment (wormwood worm ragweed, bitter wormwood, Tatar swan, annual sunflower) 5.0 ml (10 000 ± 2500 PNU / ml),

    1 bottle of test-control liquid of 4.5 ml, 7 bottles of dilution liquid of 4.5 ml in a pack of cardboard along with instructions for use.

    Storage conditions:

    Mixt allergens are stored in accordance with SP 3.3.2.1248-03 in a place inaccessible to children, at a temperature of 2 to 8 ° C.

    Transportation is carried out in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.

    Shelf life:

    Mixt-allergen - 2 years, test-control and diluting liquids - 5 years.

    The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000874 / 01
    Date of registration:24.11.2008 / 19.02.2014
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Information update date: & nbsp16.02.2016
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